Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NST
FDA 510(k) K990349 · CooperSurgical, Inc.
510(k) numberK990349
Submission
- Device name
- Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NST
- Applicant
- CooperSurgical, Inc.
Shelton, CT, US - Received
- February 5, 1999
- Decision date
- July 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQF – Catheter, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6110
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/12/2026SE |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional | Vitrolife Sweden AB | 07/23/2025SE |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 08/16/2024SE |
| K231730 | FemaSeed Intratubal InseminationMQF · Traditional | Femasys, Inc. | 09/22/2023SE |
| K220010 | Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional | Shanghai Horizon Medical Technology Co., Ltd. | 12/16/2022SE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional | Allwin Medical Devices, Inc. | 07/01/2020SE |
| K192540 | Kitazato ET CathetersMQF · Traditional | Kitazato Corporation | 05/01/2020SE |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional | Allwin Medical Devices, Inc. | 11/14/2019SE |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special | Cook Incorporated | 05/17/2019SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | Cook Incorporated | 10/24/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | 08/19/2026SE |
| K243799 | Fetal PillowPWB · Traditional | 08/29/2025SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | 04/11/2025SE |
| K223064 | ALLY II Uterine Positioning System (UPS)LKF · Special | 10/28/2022SE |
| K201086 | Advincula Delineator Uterine ManipulatorHEW · Special | 05/21/2020SE |
| K200038 | Endosee SystemHIH · Special | 02/05/2020SE |
| K191020 | G210 InviCell Plus with SignipHy pH monitoringPUB · Traditional | 01/14/2020SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | 06/12/2019SE |
| K190639 | Endosee SystemHIH · Special | 05/15/2019SE |
| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | 05/10/2019SE |
Questions and answers
When was Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NST cleared by the FDA?
Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NST (K990349) received a 510(k) decision of Substantially Equivalent on July 26, 1999, 171 days after the submission was received.
What is the product code of K990349?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.